Comparison of Vessel-FFR Versus FFR in Intermediate Coronary Stenoses
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHelios Health Institute GmbH
About this trial
This is a prospective, randomized, controlled, multicenter, open-label study designed to assess whether vFFR is non-inferior to FFR in assessment of intermediate coronary stenosis in terms of the occurrence of MACE during 12 months after randomization.
Eligibility criteria
Qualifiers
Age >18 years
Willing to participate and able to understand, read and sign the informed consent document before the planned procedure
Eligible for coronary angiography and/or PCI
Coronary artery disease in one or more native major epicardial vessels or their branches by coronary angiogram with visually assessed de novo coronary stenosis in which the physiological severity of the lesion is in question (typically 40-80% diameter stenosis).
Disqualifiers
Previous CABG with patent grafts to the interrogated vessel
Tandem stenoses separated by more than 10 mm that require separate pressure guide wire interrogation or PCI (not to be interrogated or treated as a single stenosis)
Total coronary occlusions
Hemodynamic instability (Killip class III-IV)
Trial design
Treatments tested in this trial
- measurement of FFR
- measurement of Pd/Pa
Treatment groups
1,054 Participants
are divided into 2 treatment groupsSponsors and collaborators
Helios Health Institute GmbH
Lead sponsor
Heart Center Leipzig - University Hospital
Collaborator
Source ClinicalTrials.gov